Overview Canada is one of the early implementers of medical device regulations back in 1975. Their regulations were strengthened further in 1998 with the implementation of Medical Device rules, SOR/98-282 in lines with International Medical Device Regulators Forum (IMDRF). With risk-based classification in implementation, decoding them becomes crucial for deciding on whether to apply for Establishment License and Regulatory approval. Canada also has other certification before approval. With stringent regulations for post-market surveillance and special regulations for implanted devices, procuring device market approval in the country may prove challenging. Freyr’s team of experts decode the device classification and layout the strategic roadmap for Regulatory process for in-time market approvals. Freyr also assists in preparation for compliance to Canadian Medical Device Conformity Assessment System (CMDCAS)-ISO 13485:03 and concerned document compilation. We specialize in serving end-to-end Regulatory needs of clients pertaining to Medical Devices right from device classifications to market-entry. Canada Market Entry for Medical Devices - Process Flow Freyr Expertise Regulatory Assistance for Establishment License Procurement Medical Device Classification Support for CMD CAS Procurement Document Compilation and Submission Support Post-market Surveillance Summary S. No Requirement Canada 1 Regulatory Authority Health Canada 2 Regulation Medical Devices Regulations (SOR/98-282) 3 Risk Classification Class I Class II Class III Class IV 4 Regulatory Pathway Class I No Need Class II Medical Device License Class III Class IV 5 Authorized Representative No Requirement 6 Fee payable Class I NA Class II $381* Class III $ 5,469 - $ 9310* Class IV $12,720 - $21,683* 7 QMS Requirement CMDCAS (ISO 13485) 8 Assessment of Technical Data Health Canada 9 Validity of License Unlimited 10 Labelling Requirements Part 21 of MDR (SOR/98-282) 11 Submission format Paper 12 Final Outcome Class I Establishment License Class II Medical Device License Class III Class IV 13 Timelines Class I NA Class II 15 Days Class III 60 Days Class IV 75 Days 14 Language English & French *The price is as per records at the time of documentation and is subject to change.